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Nicholas Decker

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Nicholas Decker, MBA

Head of Regulatory Policy for Global Standards, Postmarket, and Translational Policy at Roche Diagnostics

Nicholas Decker is the Head of Regulatory Policy for Global Standards, Postmarket, and Translational Policy at Roche Diagnostics. Nick focuses on shaping regulatory policy across multiple areas including global harmonization, cybersecurity, Predetermined Change Control Plans, among other post market policy issues. Nick also leads translational policy efforts aimed at monitoring and providing governance for significant changes in the global regulatory landscape. Prior to his current role, Nick led Roche Diagnostics’ EU IVDR program, guiding the organization toward industry-leading readiness for the transition to the new regulatory framework in the EU.